tranexamic acid oral (Rx)

Brand and Other Names:Lysteda
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 650mg
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Menorrhagia

Indicated for the treatment of cyclic heavy menstrual bleeding

1300 mg PO TID for up to 5 days during menstruation

Renal impairment

  • SCr >1.4 mg/dL and ≤2.8 mg/dL: 1300 mg PO BID
  • SCr >2.8 mg/dL and ≤5.7 mg/dL: 1300 mg PO qDay
  • SCr >5.7 mg/dL: 650 mg PO qDay
  • Each regimen listed above may be administered for up to 5 days during menstruation

Hereditary Angioedema (Off-label)

Long term prophylaxis: 1000-1500 mg PO q8-12hr; reduce dose to 500 mg/dose PO qDay or q12hr when frequency of attacks reduces

Short term prophylaxis: 75 mg/kg/day PO divided q8-12hr for 5 days before and after the event

Treatment of acute HAE attack: 25 mg/kg/dose PO/IV; not to exceed 1000 mg/dose q3-4hr; not to exceed 75 mg/kg/day or 1000 mg PO q6hr for 48 hr

Cone Biopsy (Off-label)

1000-1500 mg q8-12hr x12 days postop

Epistaxis (Off-label)

1000-1500 mg q8-12hr x10 days

Hyphema (Off-label)

1000-1500 mg q8-12hr x7 days

Hereditary Angioedema (Off-label)

1000-1500 mg PO BID/TID

Administration

May take with or without food

Swallow whole, do not chew, break, or crush

Indicated for women of reproductive age and is not intended for use in premenarcheal girls

Based on a pharmacokinetic study in 20 adolescent females, aged 12-16 years, no dose adjustment is needed in the adolescent population

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Interactions

Interaction Checker

and tranexamic acid oral

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      Serious - Use Alternative

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            Adverse Effects

            >10%

            Headache (50.4%)

            Nasal and sinus symptoms (25.4%)

            Back pain (20.7%)

            Abdominal pain (19.8%)

            Musculoskeletal pain (11.2%)

            1-10%

            Arthralgia (6.9%)

            Muscle cramps and spasms (5.8%)

            Migraine (6%)

            Anemia (5.6%)

            Fatigue (5.2%)

            Postmarketing Reports

            Nausea, vomiting, and diarrhea

            Allergic skin reactions

            Anaphylactic shock and anaphylactoid reactions

            Thromboembolic events (eg, DVT, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction); cases have been associated with concomitant use of combination hormonal contraceptives Impaired color vision and other visual disturbances

            Dizziness

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            Warnings

            Contraindications

            Hypersensitivity

            Women using combination hormonal contraceptives

            Active thromboembolic disease (eg, DVT, pulmonary embolism, or cerebral thrombosis)

            History of thrombosis or thromboembolism, including retinal vein or artery occlusion

            Intrinsic risk of thrombosis or thromboembolism (eg, thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy)

            Cautions

            Increased risk for thrombosis when coadministered with combination oral contraceptive (see Contraindications), Factor IX complex concentrates, anti-inhibitor coagulant concentrates, or oral tretinoin

            Retinal venous and arterial occlusion has been reported

            Severe allergic reaction reported; anaphylactic shock reported with IV product

            May cause cerebral edema and cerebral infarction in women with subarachnoid hemorrhage

            Ligneous conjunctivitis reported

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            Pregnancy & Lactation

            Pregnancy Category: B; not indicated in pregnant women

            Reproduction studies have been performed in mice, rats, and rabbits and have revealed no evidence of impaired fertility or harm to the fetus due to tranexamic acid; however, tranexamic acid is known to cross the placenta and appears in cord blood at concentrations approximately equal to the maternal concentration

            Lactation: Distributed in human breast milk at a concentration of about 1/100th of the corresponding serum concentration; should be used during lactation only if clearly needed

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Antifibrinolytic; synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin by plasmin In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin’s matrix structure

            Absorption

            Bioavailability: 45%

            Peak plasma time: 2.5 hr

            Peak plasma concentration: 16.41 mcg/mL (steady-state)

            AUC: 80.19 mcg•hr/mL

            Distribution

            Protein bound: 3%

            Vd: 0.18 L/kg (initial); 0.39 L/kg (steady-state)

            Metabolism

            Small fraction is metabolized

            Elimination

            Half-life: 11.08 hr

            Eliminated by urinary excretion primarily via glomerular filtration

            Excretion: 90% urine; >95% of the dose excreted unchanged

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.